Kornimate/medical-research-clean huggingface dataset:
effect of video education on patients' knowledge and attitudes of privacy in prenatal genetics

Conditions: Aneuploidy; Genetic Disease; Pregnancy Related

Summary: the investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes.

the investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. pregnant women undergoing specialized fetal anatomic ultrasound surveys at women and infants' maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate. volunteers will be randomized to receive either standard education about prenatal genetic testing or standard education plus additional education about federal genetic privacy protections. next, the participants view the educational materials to which they were randomized. finally, all volunteers will take the same survey, which will assess baseline demographic variables as well as their knowledge of and attitudes toward broad sharing of data obtained from prenatal genetic testing. once finished with the survey, volunteers will have completed their participation in this study.

Eligibility criteria:
inclusion criteria: * pregnant patients undergoing a scheduled l2 ultrasound at the women and infants prenatal diagnosis center (pdc) * singleton pregnancies * english speaking * results available from cell-free dna screening for this pregnancy exclusion criteria: * prior l2 ultrasound at the pdc during the current pregnancy (to avoid test-retest or multiple approach) * prior participation in this study * gestational age \ 23'6 weeks * suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation) * unscheduled / add-on l2 ultrasounds

Keywords: genetic privacy aneuploidy screening pregnancy data use data sharing protected health information
computerized health education to promote physical activity

Conditions: Hypertension

Summary: this study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. the health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.

the main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians. the primary outcome is minutes of physical activity measured by the 7-day physical activity recall interview at 6 months. the intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. based on their responses, participants received four feedback reports at each time point. the reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. the control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.

Eligibility criteria:
inclusion criteria: * ability to speak and read english * current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate) * ability to complete all written surveys * accessible for follow-up telephone surveys * ability to undergo exercise testing exclusion criteria: * currently participating in another research study * planning to move out of the philadelphia area * unable to walk without pain * pregnant or planning to become pregnant in the year following study entry * excessive drinking * coronary heart disease * congestive heart failure * peripheral vascular disease * cerebrovascular disease * chronic obstructive pulmonary disease * arrhythmia * recurrent seizures * dizziness * balance problems * psychoses

Keywords: physical activity wellness programs health promotion blood pressure, high
registry of the natural history of recurrent pericarditis in pediatric and adult patients

Conditions: Recurrent Pericarditis

Summary: the registry will focus on furthering the understanding of the natural history of recurrent pericarditis (rp), as well as document rp-related clinical, health-related quality of life (hrqol), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of rp patients to optimize clinical outcomes. it also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.


Eligibility criteria:
active rp patients select inclusion criteria: * physician-confirmed (or confirmation in medical records) diagnosis of rp defined as an initial, acute, episode and at least one pericarditis recurrence after the initial acute episode * experienced at least one pericarditis episode in the 3 years prior to inclusion * under the care of a physician for the treatment and management of rp * currently prescribed medication for rp select exclusion criteria: * diagnosis of pericarditis secondary to tuberculosis (tb), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases, except sjia and adult still's disease, hiv * appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient english or spanish proficiency that could interfere with ability to complete patient-completed assessments * currently enrolled in a therapeutic investigational drug or device study inactive rp patients select inclusion criteria: * physician-confirmed (or confirmation in medical records) diagnosis of rp defined as an initial, acute, episode and at least one pericarditis recurrence after the initial, acute episode * patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion * resolution of rp symptoms confirmed with no further rp treatment for 3 years prior to registry enrollment select exclusion criteria: * experienced a pericarditis episode within 3 years from enrolling in the registry * currently receiving rp treatment prescribed by a treating physician (e.g., cs, colchicine) * diagnosis of pericarditis secondary to tuberculosis (tb), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases except sjia and adult still's disease, hiv * enrolled in a therapeutic investigational clinical trial during the observation period
intravenous mepolizumab in subjects with hypereosinophilic syndromes (hes)

Conditions: Hypereosinophilia; Hypereosinophilic Syndrome

Summary: hypereosinophilic syndrome (hes) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia. hes has a high morbidity/mortality rate. the major treatment of hes has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications. mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hil-5) and inhibits its activity. previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and hes patients and has alleviated some hes clinical signs and symptoms. this study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in hes.

a multicenter, randomized, double-blind, placebo-controlled, parallel group phase iii study to evaluate corticosteroid-reduction and -sparing effects of mepolizumab 750 mg intravenously in subjects with hypereosinophilic syndromes (hes) and to evaluate the efficacy and safety of mepolizumab in controlling the clinical signs and symptoms of hes over nine months

Eligibility criteria:
inclusion criteria: * documented history of hypereosinophilic syndrome (hes) * eosinophil count greater than 1500 cells for 6 months * signs and symptoms of organ system involvement * no evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation. * achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication. * not pregnant or nursing. exclusion criteria: * churg-strauss syndrome * wegener's granulomatosis * lymphoma, hematological malignancy, advanced and metastatic solid tumors * chemotherapy, radiotherapy or interleukin 2 treatment.

Keywords: hypereosinophilic syndrome hypereosinophilia mepolizumab anti il-5
efficacy of iort with ct-guided hdr brachytherapy for treatment of breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

this is a prospective single-arm phase ii study designed to study the efficacy of high dose rate (hdr) brachytherapy with ct-imaging, single-fraction intraoperative radiation therapy (iort). the study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (bcs). the main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. patients may be eligible prior to receiving bcs or within 30 days of receiving bcs. eligible patients that will undergo bcs will receive surgery according to the standard clinical practice in the brachytherapy suite in the emily couric clinical cancer center. patients that have already undergone bcs must meet all other eligibility criteria and are able to be treated with iort within 30 days of their breast surgery. eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. immediately following lumpectomy, the breast hdr brachytherapy applicator will be placed and ct imaging will be performed for treatment planning. after hdr brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (ibtr), all efforts will be made to follow the patients until death.

Eligibility criteria:
inclusion criteria: 1. patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer. 2. tumor size must be less than or equal to 3 cm. 3. patient is 45 years of age or older. exclusion criteria: 1. male patients. 2. pregnant patients. 3. breast cancer that involves the skin or chest wall. 4. history of ipsilateral breast cancer. 5. multicentric breast cancer in the ipsilateral breast. 6. known brca gene mutation. 7. patient with nodal disease. 8. patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size. 9. patient with breast implants (does not include patients having implants after intra-operative radiotherapy).

Keywords: breast cancer early-stage iort brachytherapy
a study of immune phenotype biomarkers in patients with relapsing multiple sclerosis (rms) after treatment with 0.5mg fingolimod

Conditions: Relapsing Multiple Sclerosis

Summary: a study of immune phenotype biomarkers in patients with relapsing multiple sclerosis (rms) after treatment with 0.5mg fingolimod

this study used a 2-cohort, nonrandomized, open-label, multicenter design. cohort 1: the first cohort was to be comprised of approximately 200 patients with rms, who were newly prescribed commercially available fingolimod 0.5 mg/day. cohort 2: the second cohort was to be comprised of approximately 200 rms patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. patients from both cohorts were recruited simultaneously from up to 125 ms centers in the united states. both cohorts ran concurrently. the study consisted of 2 periods: screening (up to 4 weeks) and treatment period from baseline (end of screening period considered as day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing forms of multiple sclerosis * patients who started commercially prescribed fingolimod therapy 0.5mg per day or patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years exclusion criteria (per uspi): * patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or class iii/iv heart failure * history or presence of mobitz type ii second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker * baseline qtc interval ≥ 500 msec * treatment with class ia or class iii anti-arrhythmic drugs * patients who had a hypersensitivity reaction to fingolimod or any of the excipients

Keywords: relapsing multiple sclerosis rms relapsing multiple sclerosis (rms) multiple sclerosis ms multiple sclerosis (ms) fingolimod fluent immune phenotype adult fty720
study of lamotrigine 2 x 25 mg ir tablets of torrent pharmaceuticals pvt., ltd., india and lamictal ® (lamotrigine) 2 x 25 mg tablets of glaxo-smithkline, usa, in healthy human adult subjects, under fed conditions

Conditions: Healthy

Summary: * objective: * to assess the bioequivalence of lamotrigine 2 x 25 mg ir tablets of torrent pharmaceuticals pvt., ltd., india and lamictal ® (lamotrigine) 2 x 25 mg tablets of glaxo-smithkline, usa, in healthy human adult subjects, under fed conditions. * study design: * a randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (bmi) between 18 and 27 kg/m2 * subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study. * subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/principal investigator to be of no clinical significance. * informed consent given in written form according to section 11.3 of the protocol. * female subjects: 1. of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (iud), or abstinence. 2. postmenopausal for at least 1 year. 3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) exclusion criteria: * cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse or drug abuse within past one year. * moderate to heavy smoking (\> 10 cigarettes/day) or consumption of tobacco products. * history of difficulty in swallowing tablet. * clinically significant illness within 4 weeks before the start of the study * asthma, urticaria or other allergic type reactions after taking any medication. * positive urine drug screening, hiv, hepatitis b \& c tests. * any history of hypersensitivity to lamotrigine. * existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject. * inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development/impaired cerebral function.
effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic ed setting

Conditions: Cellulitis

Summary: the effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.

the investigator hope to determine if the implementation of teledermatology in the emergency department (ed) at the ohio state university wexner medical center is beneficial in diagnosing cases of cellulitis and pseudocellulitis conditions. prior studies have indicated that misdiagnosis may occur in up to 28% of patients in the ed with these conditions. additionally, dermatological consults have been shown to change diagnosis or management of these conditions in more than 60% of the patients examined. without the use of teledermatology, however, a dermatological consult would be prohibitively expensive and take time to obtain. the investigator proposes that by utilizing teledermatology in emergency rooms, the investigator can make faster, yet just as accurate, dermatological diagnoses in patients presenting with cellulitis-like symptoms. subsequently, by reducing the number of misdiagnoses, unnecessary use of antibiotics and hospitalizations will also decrease, lowering health care costs and simultaneously providing patients with faster treatment of the actual dermatologic condition.

Eligibility criteria:
inclusion criteria: * over 18 * present to the ed with cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion exclusion criteria: * pregnant * prisoner
repeatability of static & dynamic composite confocal microscopy for assessment of the corneal nerve fiber plexus in early diabetic polyneuropathy

Conditions: Normal Eyes of Subjects Without Diabetes Mellitus; Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN; Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN

Summary: this prospective study was was divided into 2 parts and carried out at 2 sites in germany. part 1 assessed repeatability in healthy, non-diabetic population (group "control"). part 2 collected data to evaluate the diagnostic and prognostic value of using heidelberg engineering retina tomograph (hrt) 3 with the rostock cornea module eyeguidance functional module (hrt rcm-e) in subjects with early to moderate dpn (groups"none" and "mild", respectively).

part 1 aimed to evaluate the diagnostic and prognostic value of the optimized dynamic composite corneal nerve plexus image acquisitions done with hrt rcm-e compared to standard static composite image acquisition with heidelberg engineering retina tomograph (hrt) 3 with the rostock cornea module (hrt rcm). the part 2 (research part) evaluated changes in corneal nerve plexus parameters in diabetes patients without or with early to moderate diabetic peripheral neuropathy (dpn) and correlated the observed changes with progression of early dpn.

Eligibility criteria:
inclusion criteria: * all * able and willing to undergo the test procedures, give consent, and to follow instructions. * signed informed consent. * ≥18 years. * part 1, site 1 * normal eyes of patients without diabetes mellitus * fasting blood glucose \< 100 mg/dl * hba1c ≤ 6.5% * part 2, site 2 * diabetes mellitus type 2 without coexisting dpn (nss score ≤2 and / or nds score ≤2) * diabetes mellitus type 2 with coexisting early to moderate dpn. (nss score 3-4 and / or nds score 3-5) * 6.5% \< hba1c ≤ 9.5% exclusion criteria: * vulnerable subjects (such as: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel (if linked to ci site), employees of the sponsor, members of the armed forces (if linked to ci site or sponsor), and persons kept in detention.) * subjects unable to read or write * contact lens wearers (soft and rigid) * patients with symptomatic dry eye * patients with conjunctivitis at the time of inclusion * patients with history of corneal surgery * patients with diabetic retinopathy * patients with history of neuronal diseases that according to the expertise of the investigator might have an influence on corneal nerve fiber plexus
the value of ct cholangiography in primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: the reason for this study is to see if a new radiologic technique called computerized tomographic cholangiography (ct cholangiography) could be helpful to demonstrate the bile ducts features and measure the amount of space of bile duct canals that should be filled with bile fluid. it may be useful to find out how well these findings correlate with the previously known clinical predictors in term of the clinical outcomes that will happen in the future for patients with primary sclerosing cholangitis (psc).

prognostic models, which have been produced based on clinical, histological and biochemical feature, are useful in predicting survival and determining timing for liver transplantation. preliminary feasibility studies in patients with psc using high resolution ct with a contrast agent (ct cholangiography), has shown excellent depiction of bile ducts. ct cholangiography also has the potential to allow quantification of intraductal volume by using sophisticated computer programs. this assessment may be an important clinical feature to assess disease severity and progression.the information about cholangiographic features could be important for therapeutic decisions (e.g., in determining the usefulness of balloon dilatation or stenting for a dominant extrahepatic duct stricture), for counseling patients, and for therapeutic trials in stratifying patients and assessing efficacy of treatment.

Eligibility criteria:
inclusion criteria: * adult males or females, age 18-70 (inclusive) with suspected psc. * serum carbohydrate antigen 19-9 (ca19-9) level in normal range (obtained within the previous year), or if greater than normal, the patient requires a negative cytologic or histologic evidence for cholangiocarcinoma within prior 3 months. * sexually active female patients of childbearing potential must be evaluated for pregnancy. a pregnancy test obtained at entry prior to the initiation of treatment must by negative. female patient must not be breast-feeding. * renal function: a creatinine less than 2.0 mg/dl or a diabetic patient with a creatinine less than 1.5 mg/dl. exclusion criteria: * evidence of cholangiocarcinoma * pregnancy or breast feeding * history of allergy to iodinated contrast agents or morphine * renal impairment as defined as known renal disease, a creatinine higher than 2.0 mg/dl or a diabetic patient with a creatinine higher than 1.5 mg/dl. * any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as significant cardiovascular dysfunction or chronic obstructive pulmonary disease requiring specific therapy.

Keywords: primary sclerosing cholangitis computed tomographic cholangiography meld score mayo risk score for psc